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Dimethicone - Medication Information

Product NDC Code 76162-496
Drug Name

Dimethicone

Type Generic
Pharm Class Skin Barrier Activity [PE]
Active Ingredients
Dimethicone 12 mg/ml
Route TOPICAL
Dosage Form LOTION
RxCUI drug identifier 876980
Application Number M016
Labeler Name TopCo Associates LLC
Packages
Package NDC Code Description
76162-496-44 532 ml in 1 bottle, plastic (76162-496-44)
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Adverse reactions

Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.
Adverse reaction DISTRIBUTED BY TOPCO ASSOCIATES LLC ITASCA, IL 60143 1-888-423-0139 ©TOPCO VIJA0623 tippytoesbrands.com Scan here for more information of call 1-888-423-0139

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Dimethicone 1.2%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions apply as needed

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, Avena sativa (oat) kernel flour, benzyl alcohol, sodium chloride, sodium hydroxide

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses helps prevent and temporarily protects chapped or cracked skin helps protect from the drying effects of wind and cold weather

Purpose

Information about the drug product’s indications for use.
Purpose Skin protectant

Spl product data elements

Usually a list of ingredients in a drug product.
Dimethicone Dimethicone WATER GLYCERIN DISTEARYLDIMONIUM CHLORIDE PETROLATUM ISOPROPYL PALMITATE CETYL ALCOHOL OATMEAL BENZYL ALCOHOL SODIUM CHLORIDE SODIUM HYDROXIDE DIMETHICONE DIMETHICONE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal panel display COMPARE TO AVEENO BABY ® DAILY MOISTURE LOTION* tippy toes ® baby lotion Daily Moisturizer Helps Soothe and Protect Baby's Skin Fragrance-Free Paraben & Phthalate Free Hypoallergenic 18 FL OZ (532 mL) image description

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
QUALITY GUARANTEED If for any reason you are not satisfied, we,ll give you a full refund. Disclaimer *This product is not manufactured or distributed by Kenvue, Inc., distributor of Aveeno Baby ® Daily Moisture Lotion.

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on deep or punture wounds animal bites serious burns

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help ot contact Poison Control right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? 1-888-423-0139

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if condition wirsens sympton last more then 7 days or clear up and occur again within a few days

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product do not get into eyes

Storage and handling

Information about safe storage and handling of the drug product.
Other information store between 15°-30°C (59°-86°F)

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API